Uterine bleeding is a commonly encountered clinical condition attributable to a variety of causes, including post-partum hemorrhages following childbirth, post-operative hemorrhages following procedures such as dilation and curettage, and dysfunctional uterine bleeding. Severe uterine bleeding resulting from conditions other than those of the normal menstrual cycle can be a serious problem. For example, about 500 ml. or more of blood is lost in 50% of all childbirths. It can lead to exsanguination, the possibility of peritoneal irritation or infection and other dangerous situations. Hemorrhage is, in fact, one of the major causes of maternal mortality. In one study, maternal death was attributed to hemmorhage in 30% of all maternal deaths. Accordingly, it is desirable to control such bleeding, if possible, at its onset.
Among the various intrauterine devices described in the prior art are those disclosed in U.S. Pat. Nos. 3,933,152, issued Jan. 20, 1976 to Moulding; 3,933,153, issued Jan. 20, 1976 to Csatary et al; 3,994,291, issued Nov. 30, 1976 to Salmasian; 3,918,443, issued Nov. 11, 1975 to Vennard and 3,464,409, issued Oct. 21, 1965 to Murphy. Each of these patents discloses inflatable intrauterine devices which conform to the shape of the uterus.
U.S. Pat. No. Re. 29,207, reissued May 10, 1977 to Bolduc et al. and U.S. Pat. No. 3,934,580, issued Jan. 27, 1976 to Cournout, disclose intrauterine devices capable of dispensing materials into the uterus or fallopian tubes.
None of the aforementioned patents disclose the use of any device to withdraw materials from the uterine cavity. Nor are the devices disclosed designed for or useful for controlling uterine bleeding.
U.S. Pat. No. 2,122,579, issued July 15, 1938 to Meckstroth, discloses an intrauterine device having a semirigid non-inflatable head which conforms to the shape of the uterus and an insertion member which acts as a capillary draw. Meckstroth discloses that the purpose of his device is to remove debris from the uterus to relieve amenorrhea and dysmenorrhea. However, no mention is made in the Meckstroth patent of the use of this or any other device to exert pressure on the uterine walls or to control uterine bleeding in any manner.